- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928485
Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer
Randomized Study of Sunphenon Decaffeinated Capsules in Men With Low-Risk Prostate Cancer on Active Surveillance
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy.
SECONDARY OBJECTIVES:
I. To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid [DNA]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue.
II. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients undergo active surveillance for 52 weeks.
ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
- Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible
- Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents
- Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
- Willing and able to take oral medications
- Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study
- Subjects must have newly diagnosed (within 1 year), previously untreated prostate cancer without other malignancy; therefore, no prior therapies are permitted
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ institutional upper limit of normal
- Serum creatinine within normal institutional limits
Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:
- Beer: 12 fluid ounces (355 milliliters)
- Wine: 5 fluid ounces (148 milliliters)
- Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters)
Exclusion Criteria:
- Patients who are receiving any other investigational agents
- Patients with known concurrent malignancy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunphenon 90 DCF-T or other agents used in this study
- Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have received prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
- Signs or symptoms of progressive or uncontrolled liver disease
- Known malignancy at any site within the last two years; with the exception of basal cell carcinoma (BCC)
- Participation in a research trial within the past three months
- Any condition that would interfere with the ability to give informed consent or comply with the study protocol
- Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
- Patients with a known history of Gilbert's syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A (active surveillance)
Patients undergo active surveillance for 52 weeks.
|
Correlative studies
Ancillary studies
Other Names:
Undergo active surveillance
|
Experimental: Arm B (Sunphenon)
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Ancillary studies
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total-PSA (tPSA) Levels
Time Frame: From baseline at 52 weeks
|
tPSA serum levels
|
From baseline at 52 weeks
|
Changes in the f/tPSA Ratio
Time Frame: From baseline at 52 weeks
|
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
|
From baseline at 52 weeks
|
Changes in IGF-I Levels
Time Frame: Baseline to 52 weeks
|
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
|
Baseline to 52 weeks
|
Changes in the IGF-I/fPSA Ratio
Time Frame: Baseline up to 52 weeks
|
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
|
Baseline up to 52 weeks
|
Changes in the Level of IGFBP-3
Time Frame: Baseline to 52 weeks
|
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
|
Baseline to 52 weeks
|
Changes in the Level of VEGF
Time Frame: Baseline up to 52 weeks
|
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
|
Baseline up to 52 weeks
|
Changes in the Levels of Free-PSA (f-PSA)
Time Frame: from baseline at 52 weeks
|
The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.
|
from baseline at 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)
Time Frame: Up to 52 weeks
|
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).
|
Up to 52 weeks
|
Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67
Time Frame: Up to 52 weeks
|
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
|
Up to 52 weeks
|
Effects of Oral Ingestion of Green Tea Extract on Levels of CD34
Time Frame: Up to 52 weeks
|
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
|
Up to 52 weeks
|
Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue
Time Frame: Up to 52 weeks
|
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.
|
Up to 52 weeks
|
Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture
Time Frame: Up to 52 weeks
|
Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz.
shape, size and texture
|
Up to 52 weeks
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Time Frame: Baseline
|
Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26).
Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
|
Baseline
|
Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Time Frame: At 24 weeks
|
Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26).
Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
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At 24 weeks
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Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores
Time Frame: at 3.5 years from start of study
|
Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26).
Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
|
at 3.5 years from start of study
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Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Time Frame: Baseline
|
Quality of Life (QOL) assessed by SF-12.
The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS).
The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
|
Baseline
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Time Frame: At 24 weeks
|
Quality of Life (QOL) assessed by SF-12.
The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS).
The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
|
At 24 weeks
|
Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12)
Time Frame: At 3.5 years from start of study
|
Quality of Life (QOL) assessed by SF-12.
The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS).
The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
|
At 3.5 years from start of study
|
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Time Frame: Baseline
|
Urinary symptoms as assessed by American Urological Association Symptom Index (AUA).
This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency.
Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
|
Baseline
|
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Time Frame: At 24 weeks
|
Urinary symptoms as assessed by American Urological Association Symptom Index (AUA).
This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency.
Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
|
At 24 weeks
|
Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA)
Time Frame: At 3.5 years from start of study
|
Urinary symptoms as assessed by American Urological Association Symptom Index (AUA).
This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency.
Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.
|
At 3.5 years from start of study
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Sexual Health Inventory in Men Score (SHIM Score)
Time Frame: Baseline, at 24 weeks, and at 3.5 years from start of study
|
SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows: 22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction Reported values are an average of three collected data points per participant: at baseline, at 24 weeks, and at end of study (3.5 years) |
Baseline, at 24 weeks, and at 3.5 years from start of study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lee Ponsky, MD, Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE6812
- NCI-2013-01372 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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